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New treatment option for Pain, Postoperative
Official title Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
ClinicalTrials.gov ID: NCT06379425
What this study is testing
What is Acetaminophen?
Acetaminophen is an investigational medicine, being studied as a potential treatment for pain, postoperative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing...
- In good general health as evidenced by medical history
- Ability to take oral medication and be willing to adhere to the study intervention
You likely can't join if
- Pregnancy or lactation
- Younger than age 18
- Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
- Patients with Myasthenia Gravis, renal disease with CrCl \< 50, seizure disorder, substance use disorder, anaphylaxis and angioedema to gabapentin...
- Patients with a , history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric...
- Patients with compromised renal function who are notable to receive NSAIDs
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing transvaginal minor urogynecologic surgery (midurethral sling...
- In good general health as evidenced by medical history
- Ability to take oral medication and be willing to adhere to the study intervention
- Patients may be English or Spanish-speaking and must be able to provide informed consent
- Pregnancy or lactation
- Younger than age 18
- Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
- Patients with Myasthenia Gravis, renal disease with CrCl \< 50, seizure disorder, substance use disorder, anaphylaxis and angioedema to gabapentin, Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), driving...
- Patients with a , history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric bypass surgery, heart failure, active GI ulcer, active GI bleeding...
- Patients with compromised renal function who are notable to receive NSAIDs
- Patients with significant cardiovascular disease, such as patients with heart failure
- Patient with recent evidence of worsening fluid retention
- Both non-English and non-Spanish speaking patients
- Urogynecologic surgeries for apical repair (sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis)
- Current use of illicit substances (cocaine, non-prescription opioids, marijuana)
- Current use of gabapentin as home medication
The study team makes the final eligibility decision.
Where it's taking place
- Bay Shore, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bay Shore, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.